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Active Not Recruiting
NCT05677763
OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness
Conditions: Respiratory Tract Infections, Wheezing Lower Respiratory Illness
Sex: All
Ages: 6 Months – 5 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 525
Sponsor: OM Pharma SA
Location: Ludwig Maximilians Universität München München Bavaria
Summary
This study will assess the efficacy and safety of OM-85 compared to placebo in reducing the number of respiratory tract infections (RTIs) in children aged between 6 months and 5 years.
Eligibility Criteria
Inclusion Criteria:
* Children of either gender aged between 6 months and 5 years, at Baseline/Randomisation (Visit 2) inclusive.
* For children ≥1 year of age, ≥4 RTIs (as reported by parents or LAR of subject), including ≥2 episodes of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 12 months prior to enrolment.
OR
* For children \
Source: ClinicalTrials.gov (NCT05677763). StuddyBuddy aggregates publicly available trial information.
